Industry-sponsored Ghostwriting in Clinical Trial Reporting: A Case Study

Account Res. Jul-Sep 2008;15(3):152-67. doi: 10.1080/08989620802194384.

Abstract

In this case study from litigation, we show how ghostwriting of clinical trial results can contribute to the manipulation of data to favor the study medication. Study 329 for paroxetine pediatric use was negative for efficacy and positive for harm. Yet the ghostwritten publication from this study concluded that paroxetine provided evidence of efficacy and safety and continues to be influential. Despite the role of named authors in revisions of the manuscript, the sponsor company remained in control of the message.

Publication types

  • Legal Case
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Authorship*
  • Clinical Trials as Topic / ethics*
  • Drug Industry / ethics*
  • Fraud*
  • Paroxetine / adverse effects
  • Paroxetine / therapeutic use
  • Serotonin Uptake Inhibitors / adverse effects
  • Serotonin Uptake Inhibitors / therapeutic use
  • Treatment Outcome
  • Writing*

Substances

  • Serotonin Uptake Inhibitors
  • Paroxetine